EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results
Envoy Medical Inc. (NASDAQ: COCH ) on Tuesday reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data. The company said participants achieved a mean Consonant-Nucleus-Consonant (CNC) word recognition score of 53.2% at the 12-month mark, compared with a pre-implantation baseline of 15.2%. The 38.0 percentage point improvement exceeded the 24.0 percentage point gain reported after six months, when the cohort posted a mean score of 39.2%. Read Also: EXCLUSIVE: Envoy Medical Hits Trial Milestone For Cochlear Implant Designed To Work With Natural Ear The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study. Majority Of Patients Showed Positive Resp...
Envoy Medical Inc. (NASDAQ: COCH ) on Tuesday reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data. 2%. 2%.
Read Also: EXCLUSIVE: Envoy Medical Hits Trial Milestone For Cochlear Implant Designed To Work With Natural Ear The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study. Majority Of Patients Showed Positive Response Nine of the 10 Stage 1 participants demonstrated hearing improvements consistent with the overall trend, while one participant was identified as a potential non-responder. Envoy Medical said it is reviewing the underlying cause of that outcome. 2 percentage point improvement from baseline.
On the safety front, the company reported no serious adverse events, as defined by the study protocol, among the first 10 participants through their 12-month follow-up visits. Envoy Medical Says Stage 2 Enrollment Complete The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1 of Envoy Medical’s two-stage pivotal trial. Following FDA authorization to expand the study, the company moved into Stage 2, which is now fully enrolled. All participants have completed their one-month visits, while many have also reached their three- and six- month follow-up milestones.
The company is collecting additional study measures and will include them in its planned FDA Premarket Approval submission. Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by the early second quarter of 2027, with a Premarket Approval submission planned several months later. 67 during premarket trading on Tuesday, according to Pro data. Read Also: Mohamed El-Erian Says Kevin Warsh Is 'Serious' About Reforming the Fed, Restoring Political Independence Photo by PeopleImages via Shutterstock